Catalog Number

190-61-04

Brand Name

Alteon

Version/Model Number

190-61-04

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K182462

Product Code

KWL

Product Code Name

Prosthesis, Hip, Hemi-, Femoral, Metal

Public Device Record Key

dafe7b8e-c76a-4eb3-b7b0-864c88b662c6

Public Version Date

January 03, 2019

Public Version Number

1

DI Record Publish Date

December 03, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-